Title:  Sr. Scientist

Job Title:          Senior Scientist

Summary:

• This position supports the parenteral pharmaceutical manufacturing facility through the qualification and/or validation of raw materials, components and manufacturing processes. Validation activities include research, protocol writing/execution and final report generation. Additionally, investigations of manufacturing challenges are conducted, and process improvements are evaluated/ implemented. Final documents are archived and may be included in or support A/NDA submissions, and made available as needed during FDA, MHRA, and client/customer compliance audits.

Essential Duties and Responsibilities:  

• Applies thorough understanding of cGMP, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
• Performs a variety of projects/studies in areas that include Raw Material Qualification (API and Excipients), Components Qualification (Primary & Secondary Components), as well as projects/studies to support implementation / filling.
• Handles projects that are more complex and broader in scope, such projects require team leadership, task prioritization, and management of budget and/or time constraints.  Must demonstrate competent and effective planning, coordination, and organizational skills.
• Writes/Reviews RMQ / Sampling protocols, reports, Change Controls. Conducts Studies/Executes protocols.
• Provides mentoring and leadership to less experienced staff.

Qualifications            

• Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
• Proficient in Microsoft Word and Excel, Visio. Proficient in technical writing.
• Sound industry knowledge, project proficiency, and autonomy expected.  May be considered a Subject Matter Expert (SME) in various disciplines including RMQ stream. 
• Knowledgeable of FDA guidelines for Justification of Specification (JOS) and RMQ documents.
• Proficient in writing Change Controls, CAPAs, Investigations, Protocols, Reports and Deviations.
• Must be able to identify opportunities for optimization of processes within the department or the plant.
• Ability to work independently or in teams.  
• Ability to walk some distance 1-3 miles, stand for 3-6 hours and lift 10 - 40 lbs. during the course of a work day as required.
• Ability to work any shift (1st, 2nd, or 3rd) and any day of the week (7 days) as duties require.

Education and/or Experience        

• BS preferably in the Engineering/Pharmaceutical Sciences (other degrees accepted provided the individual has relevant equipment validation experience) having a minimum of 5+ years related experience or 4+ years related experience w/ an advanced degree.

Location:  

Cherry Hill, NJ, US, 08003